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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chamber, Patient Isolation
510(k) Number K874306
Device Name INFECTIOUS DISEASE PROTECTION KIT, DISPOSABLE
Applicant
Busse Hospital Disposables, Inc.
P.O. Box 11067
Hauppauge,  NY  11788
Applicant Contact PARTHA BASUMALLIK
Correspondent
Busse Hospital Disposables, Inc.
P.O. Box 11067
Hauppauge,  NY  11788
Correspondent Contact PARTHA BASUMALLIK
Regulation Number880.5450
Classification Product Code
LGM  
Date Received10/20/1987
Decision Date 03/22/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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